Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

NCT ID: NCT03113591

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-29
• Study Completion Date: 2019-01-03

Brief Summary

Osteo introducer system is the instruments used in minimal invasive THA. This study will compare the minimal invasive THA using the osteo introducer system and THA using common instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of THA surgery.

Conditions

Joint Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osteo introducer group

undergo minimal invasive total hip arthroplasty surgery

Group Type: EXPERIMENTAL

Minimum invasive total hip arthroplasty

Intervention Type: PROCEDURE

Minimum invasive total hip arthroplasty using the osteo introducer system

Control group

undergo common total hip arthroplasty surgery

Group Type: ACTIVE_COMPARATOR

Common total hip arthroplasty

Intervention Type: PROCEDURE

Common total hip arthroplasty using common instruments

Interventions

Minimum invasive total hip arthroplasty

Minimum invasive total hip arthroplasty using the osteo introducer system

Intervention Type: PROCEDURE

Common total hip arthroplasty

Common total hip arthroplasty using common instruments

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• With indications of total hip arthroplasty (e.g. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis; rheumatoid arthritis; correction of functional deformity, etc.)
• BMI<30
• Subject is a candidate for primary total hip arthroplasty
• No obvious congenital abnormality in hip joint
• Subject has no mental illness, is willing to join the study voluntarily and sign the approved informed consent document; is willing and able to complete required study visits or assessments

Exclusion Criteria

• Subjects with inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
• Overt infection
• Distant foci of infections
• Allergy to metals
• Rapid disease progression as manifested by joint destruction or bone absorption apparent on X-ray
• Skeletally immature
• Neuropathic joints
• Hepatitis or HIV infection
• Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
• Pregnant or lactating women
• Subjects enrolled in another drug or device clinical investigation within 3 month
• Investigator has judged the subject is not suitable for the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou MicroPort OrthoRecon Co. LTD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

MP-GJ15-01

Identifier Type: -

Identifier Source: org_study_id